The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Hospital de Zafra
Zafra, Badajoz, Spain
Hospital de Henares
Henares, Madrid, Spain
Hospital Clínico Granada
Granada, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Universitario Virgen del Rocío
Number and severity of adverse reactions as a measure of safety and tolerabitity
Time frame: Across 12-15 weeks treatment period
Immunoglobulin changes from baseline
Subrogate efficacy
Time frame: At baseline and 1 week after last administered dose
Skin reactivity changes from baseline
Subrogate efficacy parameter. The patients will undergo a skin prick test at baseline and 1 week after last administered dose. The wheal are in mm2 will be measured and the results of both time frames will be compared.
Time frame: At baseline and 1 week after last administered dose
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Seville, Spain